Letters, Testimony & Comments

The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.

In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…

We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…

In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments.

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS’s/the Agency’s) Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics,…

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Committee on Education and the Workforce’s (Committee’s) Request for Information on Reforms to Increase Affordability and Quality in Employer…

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.

The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…

We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions.

CMS proposes updates to the RxHCC to reflect the impact of the new 2025 Part D benefit structure per the Inflation Reduction Act (IRA).